Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET

FDA device recall Z-0848-2021 · posted 2021-01-18 · Terminated

Recall details

Recalling firm

Penumbra Inc.

Reason for recall

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.

Action taken

On 12/15/2020, the firm posted a press release (https://www.penumbrainc.com/wp-content/uploads/2020/12/JET-7XF-15Dec20.pdf) and issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter via FedEx informing customers that all configurations of their reperfusion catheters may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death. Customers are instructed to: 1. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 2. Immediately review your inventory for the specific catalog numbers listed above. 3. Remove all units from inventory and place them in quarantine for return to Penumbra, Inc. 4. Complete and return the attached product identification / return form within 3 business days. 5. Continue to report adverse events and quality problems experienced with the use of this product. Adverse events and quality problems may be reported to FDA s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax. For more information, please see https://www.accessdata.fda.gov/scripts/medwatch/index.cfm. The Recalling Firm will contact customers directly to arrange return of affected units and replace/refund returned product. If customers have any questions or concerns, they can contact the Recalling Firm's Customer Service (order@penumbrainc.com or 1.888.272.4606), available Monday - Friday 7:30 AM to 4:00 PM PST, or their sales representative.

Root cause

Process design

Status

Terminated

Product code

NRY

Quantity affected

3,368 catheters

Distribution

Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, N

Date initiated

2020-12-15

Date posted

2021-01-18

Date terminated

2024-05-14

Location

Penumbra Alameda, CA

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