Home › PENUMBRA, INC. › RED 68
RED 68
PENUMBRA, INC. · Model RED68HFKIT-A · UDI-DI 00815948024137
NRY
Prescription
1
510(k) clearances
8,617
Adverse events (896 deaths)
26
Recalls
59
Facilities
Description
Reperfusion Catheter RED 68 Kit, 132cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-03 | Penumbra, Inc. | Due to manufacturing issues, reperfusion catheters may fractures |
| 2025-02-26 | Qapel Medical Inc. | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur. |
| 2025-01-02 | Scientia Vascular, Inc. | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier. |
| 2024-08-05 | MICROVENTION INC. | Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date. |
| 2024-04-23 | Stryker Neurovascular | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so t |
| 2024-03-08 | ROUTE 92 MEDICAL INC | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| 2021-08-13 | IMPERATIVE CARE INC | There is a potential for distal end of catheters to fracture and become detached. |
| 2020-12-15 | Penumbra Inc. | 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 dama |
| 2020-12-15 | Penumbra Inc. | 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 dama |
| 2020-12-15 | Penumbra Inc. | 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 dama |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.