RED 43
RED 43 is a reperfusion catheter used within the Penumbra aspiration system. It directs suction from an external pump to an intracranial thrombus, providing the catheter pathway through…
RED 43 is a reperfusion catheter used within the Penumbra aspiration system. It directs suction from an external pump to an intracranial thrombus, providing the catheter pathway through which clot material is aspirated.
The catheter connects to the pump through aspiration tubing and a collection canister. A guidewire and guide catheter or sheath provide the delivery path, while the aspiration circuit performs the clot-removal function.
Listed Item
Reperfusion Catheter RED 43 Kit, 162cm, Jon Snow Tubing, no CE
System Accessories
A separate Penumbra Separator can clear the catheter lumen if it becomes blocked with thrombus. A steam-shaping mandrel and rotating hemostasis valve are supplied with the reperfusion catheter, serving preparation and access roles within the larger system.
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) | K222808 |
| Record published | 2023-01-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RED43138-A | In distribution | |
| RED43167-A | In distribution | |
| RED43HFKIT167-A | In distribution | |
| RED43KIT-A | In distribution | |
| RED43KIT160-A | In distribution | |
| RED43HFKIT136-A | In distribution | |
| RED43160-A | In distribution | |
| RED43136-A | In distribution | |
| RED43HFKIT160-A | In distribution | |
| RED43153-A | In distribution | |
| RED43KIT153-A | In distribution | |
| RED43HFKIT138-A | In distribution | |
| RED43KIT136-A | In distribution | |
| RED43HFKIT162-A | In distribution | |
| RED43HFKIT153-A | In distribution | |
| RED43KIT167-A | In distribution | |
| RED43KIT138-A | In distribution | |
| RED43-A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penumbra System | Penumbra Inc. | 100 |
| 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
5 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-06-03 | Class II | Under Investigation by firm | Due to manufacturing issues, reperfusion catheters may fractures | ||
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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.