Device recall: Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter)…
Class II FDA enforcement event 99591. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Due to manufacturing issues reperfusion catheters may fracture.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Penumbra Inc. started this device recall on 24 Jul 2026. The firm address in the FDA record is in Alameda, CA. FDA put the recall in Class II. FDA event 99591 has 1 product record. The first FDA enforcement report date is 7 Oct 2026. The record gives the status Ongoing. 278 of the 677 device events that started in 2026 have more product records. The median device event of 2026 has 1 product record.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
Recalling firm
Penumbra Inc., Alameda, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3331-2026 | Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description is provided in Attachment 1 (HHE-2026-002… | 43 | Class II | Ongoing | 7 Oct 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 677
- Share of these events in Class II
- 87%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Jun 2026 | Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT | Device | Class II | 1 |
| 15 Dec 2020 | Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET | Device | Class I | 4 |
| 9 Jun 2017 | Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic s | Device | Class I | 1 |
Official channels
- FDA enforcement report Z-3331-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 99591. https://recallregister.com/fda/ii/99591/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 27 Oct 2026
- Newest FDA report date on the register
- 21 Oct 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
- What quantity of product is in FDA event 99591?
- The FDA record gives this quantity:
43
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 677 device events that started in 2026 are in Class II.