ACE
RC ACE 64, 127cm
5manufacturers in China registered for this device type
14catalogue 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) | K142458 |
| Record published | 2020-05-06 |
| Record revised | 2026-02-25 (version 6) |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5MAXACE068-R | In distribution | |
| 5MAXACE064L127 | In distribution | |
| 5MAXACE064 | In distribution | |
| 5MAXACE068KIT | In distribution | |
| 5MAXACE068L120 | In distribution | |
| 5MAXACE064L115 | In distribution | |
| 5MAXACE068L127 | In distribution | |
| 5MAXACE068L125 | In distribution | |
| 5MAXACE068 | In distribution | |
| 5MAXACE064L120 | In distribution | |
| 5MAXACE068KIT-R | In distribution | |
| 5MAXACE064KIT | In distribution | |
| 5MAXACE064L125 | In distribution | |
| 5MAXACE068L115 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Penumbra System | Penumbra Inc. | 100 |
| RED 43 | Penumbra Inc. | 18 |
| Solitaire™ X-Pack | Micro Therapeutics, 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.