Penumbra System Reperfusion Catheter 032, catalog number… recallZ-0428-2011 · Penumbra Inc. · initiated Oct 25, 2010
Terminated All recalls posted in November 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Penumbra Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Penumbra issued an Urgent Voluntary Field Removal letter dated October 28, 2010 to consignees, identifying the affected device and actions to be taken by consignees. Customers were instructed to inspect their inventory for the affected product and quarantine it, pending return to Penumbra. Penumbra employees will contact customers to arrange return and replacement of affected units. Customers were also requested to complete and return a product identification form and return form to Penumbra within 5 business days. Customers can contact Penumbra at 1 510 748-3223 concerning this action.
Recall details
- Recall number
- Z-0428-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 25, 2010
- Posted by the FDA
- Nov 24, 2010
- Recalling firm
- Penumbra Inc.
- Quantity
- 61
- Product code
- NRY
- FDA submissions
- K072718
- Distribution
- Worldwide Distribution: 17 consignees in the US, including in the states of CA, FL, HI, ID, IL, KY, MA, MS, NJ, NY, PA, and TX, 1 in Canada and 21 in the EU countries of France, Germany, Hungary, Italy, Norway, Slovenia, Spain, and the United Kingdom.
Product description
Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.
Code information (models, lots, serial numbers)
Lot number F15020
Other devices under the same FDA submission
3 devices cleared under K072718 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Penumbra System PSC026Penumbra, Inc. · CATHETER, THROMBUS RETRIEVER1 report
- Penumbra System PSC032Penumbra, Inc. · CATHETER, THROMBUS RETRIEVER1 report
- Penumbra System PSS032Penumbra, Inc. · CATHETER, THROMBUS RETRIEVER1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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