Penumbra System
The Penumbra System Engine Canister Assembly is a disposable fluid-collection component in a catheter-based aspiration system. The canister connects to the aspiration engine and collects…
The Penumbra System Engine Canister Assembly is a disposable fluid-collection component in a catheter-based aspiration system. The canister connects to the aspiration engine and collects material drawn through the system tubing during a procedure.
The canister sits between the vacuum source and aspiration pathway as part of the Penumbra System. It is a system accessory, separate from the pump, tubing and aspiration catheter.
Listed Item
PS Engine Canister Assembly, CE
Aspiration Circuit
The Engine provides vacuum to the aspiration pathway. The disposable canister receives the aspirated material and connects with system tubing, while a separate catheter provides access to the target vessel.
Penumbra lists the Engine source, canister, tubing and reperfusion catheters as distinct system components. The canister assembly is a fluid collection part within that circuit. FDA documentation treats the canister and aspiration tubing as distinct system parts.
5manufacturers in China registered for this device type
100catalogue numbers in this listing
25510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
Record
| Listed by | Penumbra Inc., United States |
|---|---|
| FDA product code | NRY |
| Device type | Catheter, Thrombus Retriever |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K090752 |
| Record published | 2016-07-30 |
| Record revised | 2026-02-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5MAXACE132 | In distribution | |
| 5MAXACE068-A | In distribution | |
| PSC041 | In distribution | |
| 3MAXCKIT-A | In distribution | |
| J7XKIT132-A | In distribution | |
| 5MAXJET7L127 | In distribution | |
| 5MAXACE127 | In distribution | |
| 5MAXJET7L127-A | In distribution | |
| 5MAXACE068L115-A | In distribution | |
| PSC026 | In distribution | |
| 5MAXJET7-B | In distribution | |
| PSC054L127-B | In distribution | |
| 5MAXACE115 | In distribution | |
| 4MAXCKIT | In distribution | |
| PSR3D | In distribution | |
| PST2 | In distribution | |
| 5MAXACE125-A | In distribution | |
| 5MAXACE132KIT-A | In distribution | |
| 5MAXJET7KIT-A | In distribution | |
| PSS026 | In distribution | |
| PSF026 | In distribution | |
| 5MAXJET7KIT-R | In distribution | |
| 5MAXJET7-A | In distribution | |
| 5MAXACE064L127-A | In distribution | |
| 5MAXACE068KIT-B | In distribution | |
| 5MAXACE127-A | In distribution | |
| 5MAXJET7-S | In distribution | |
| J7XBKIT132-B | In distribution | |
| ACE603D3MXSYS-A | In distribution | |
| PAPS3-A | In distribution | |
| PSF041 | In distribution | |
| 5MAXJET7L120 | In distribution | |
| 5MAXJET7L138KIT-B | In distribution | |
| 5MAXJET7L125-A | In distribution | |
| J7XKIT132 | In distribution | |
| 5MAXACE068L125-B | In distribution | |
| 5MAXACE068KIT-A | In distribution | |
| PSC054-B | In distribution | |
| 5MAXACE068L127-B | In distribution | |
| 5MAXJET7L125-B | In distribution | |
| PMXENGN | In distribution | |
| 4MAXC130 | In distribution | |
| PST3 | In distribution | |
| 3MAXCKIT | In distribution | |
| PSC032 | In distribution | |
| ACE643D3MXSYS-A | In distribution | |
| 5MAXACE068L125-A | In distribution | |
| 5MAXACE064L125-A | In distribution | |
| 5MAXJET7BKIT-A | In distribution | |
| PSR3D-A | In distribution | |
| 5MAXACE064L115-A | In distribution | |
| 5MAXJET7 | In distribution | |
| 5MAXJET7L115-A | In distribution | |
| 5MAXACE132-A | In distribution | |
| J7XBKIT132-A | In distribution | |
| 4MAXCMP | In distribution | |
| 5MAXACE125 | In distribution | |
| PMXENGN-A | In distribution | |
| 5MAXJET7L138-B | In distribution | |
| 5MAXACE068L127-A | In distribution | |
| PSS054 | In distribution | |
| 3MAXCKIT-B | In distribution | |
| PSR3D-C | In distribution | |
| 5MAXJET7BL120-A | In distribution | |
| PSC054L125-B | In distribution | |
| 5MAXJET7BL125-A | In distribution | |
| 5MAXACE068L115-B | In distribution | |
| PSF032 | In distribution | |
| PSF054 | In distribution | |
| 5MAXJET7KIT-B | In distribution | |
| 5MAXACE068L120-B | In distribution | |
| 5MAXJET7BL127-A | In distribution | |
| 3MAXC | In distribution | |
| PAPS3 | In distribution | |
| 5MAXJET7-R | In distribution | |
| 3MAXS | In distribution | |
| ACE683DVELSYS-A | In distribution | |
| 5MAXJET7KIT | In distribution | |
| 5MAXJET7L125 | In distribution | |
| 5MAXJET7L120-B | In distribution | |
| ACE683D3MXSYS-A | In distribution | |
| PSC054KIT | In distribution | |
| 5MAXACE068L120-A | In distribution | |
| 5MAXACE064L120-A | In distribution | |
| 5MAXJET7B-A | In distribution | |
| 5MAXJET7BL115-A | In distribution | |
| 5MAXJET7L115-B | In distribution | |
| PSS041 | In distribution | |
| PSS032 | In distribution | |
| 5MAXACE064-A | In distribution | |
| 5MAXJET7L120-A | In distribution | |
| 5MAXJET7KIT-S | In distribution | |
| 5MAXJET7L115 | In distribution | |
| 3MAXC-A | In distribution | |
| 5MAXACE068-B | In distribution | |
| 3MAXC-B | In distribution | |
| PST1 | In distribution | |
| 4MAXC | In distribution | |
| 5MAXACE064KIT-A | In distribution | |
| 5MAXJET7L127-B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RED 43 | Penumbra Inc. | 18 |
| Solitaire™ X-Pack | Micro Therapeutics, Inc. | 14 |
| ACE | Penumbra Inc. | 14 |
| Raptor Aspiration Catheter | Balt USA, LLC | 13 |
| Cereglide | Cerenovus, Inc. | 13 |
| Solitaire™ | Micro Therapeutics, Inc. | 9 |
| Solitaire™ X | Micro Therapeutics, Inc. | 9 |
| RED 68 | Penumbra Inc. | 9 |
| Riptide™ | Micro Therapeutics, Inc. | 9 |
| Zoom™ Reperfusion Catheter | Imperative Care Inc. | 9 |
| CaptureTM | Micro Therapeutics, Inc. | 8 |
| Esperance | Shanghai Wallaby Medical Technologies Co., Inc. | 6 |
Showing 12 of 80. All products under Catheter, Thrombus Retriever
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250690 | 2026-06-10 |
| K242104 | 2025-02-13 |
| K222808 | 2022-12-20 |
| K211654 | 2021-08-16 |
| K211411 | 2021-07-01 |
| K203440 | 2021-05-20 |
| K202251 | 2020-08-31 |
| K191946 | 2020-02-27 |
| K190010 | 2019-06-16 |
| K190464 | 2019-04-26 |
| K182522 | 2018-10-12 |
| K173761 | 2018-08-17 |
| K180008 | 2018-06-20 |
| K162901 | 2017-04-20 |
| K161640 | 2016-07-12 |
| K161064 | 2016-06-12 |
| K160449 | 2016-05-25 |
| K152541 | 2016-01-13 |
| K151623 | 2015-08-06 |
| K142458 | 2015-05-22 |
| K133317 | 2014-05-13 |
| K113163 | 2011-11-23 |
| K100769 | 2010-05-21 |
| K090752 | 2009-09-21 |
| K072718 | 2007-12-28 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Penumbra Inc. | 510(k) number | 2020-12-15 | Class I | Process design | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. | 3,368 catheters | 2024-05-14 |
| Penumbra Inc. | 510(k) number | 2020-12-15 | Class I | Process design | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. | 27,499 catheters | 2024-05-14 |
| Penumbra Inc. | 510(k) number | 2020-12-15 | Class I | Process design | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. | 0 catheters | 2024-05-14 |
| Penumbra Inc. | 510(k) number | 2020-12-15 | Class I | Process design | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. | 15 catheters | 2024-05-14 |
| Penumbra Inc. | 510(k) number | 2017-06-09 | Class I | Component change control | Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death. | 155 units | 2019-05-09 |
| Penumbra Inc. | 510(k) number | 2010-10-25 | Not classified | Process control | Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment. | 61 | 2011-06-01 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason |
|---|---|---|---|
| 2026-06-03 | Class II | Under Investigation by firm | Due to manufacturing issues, reperfusion catheters may fractures |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.