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Class I Medical Device Recall: Penumbra System Reperfusion Catheter 032

Posted Dec 08 2010 12:00am

Recall Class: Class I

Date Recall Initiated: October 25, 2010

Product(s): Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number F15020. 77 devices are subject to this recall of which 28 are marketed within the United States.

The Company issued an Urgent Voluntary Field Removal letter dated October 28, 2010 to customers, identifying the affected device. 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 it to the Company within 5 business days.

Reason for Recall: As a result of a manufacturing error, mid-shaft joint failures were occurring in some Reperfusion Catheters 032 produced from lot F15020.

Use: The Penumbra System Reperfusion Catheter 032 is used to re-establish the blood supply to the brain in patients experiencing stroke.

Recalling Firm:
Penumbra, Inc.
1351 Harbor Bay Pkwy
Alameda, CA 94502

Public Contact:
Penumbra, Inc. at info@penumbrainc.com or call 1- 510-748-3200, or 1-888-272-4606

FDA District: San Francisco

FDA Comments:

The company is advising customers to discontinue use of the product.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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