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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86989

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 15, 2020
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Penumbra Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Z-0848-2021
Recall number
Z-0848-2021
Initiated
December 15, 2020
Classification
Class I
Status
Terminated
Recalling firm
Penumbra Inc.
Quantity
3,368 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Name: Penumbra JET 7 Reperfusion Catheter Catalog Number: 5MAXJET7 UDI Code: 00815948020955 Lot Number Range: C15558 thru C17703 F87621 thru F101011 H10851

Distribution pattern

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, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.

device · product 2 of 4

Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Z-0849-2021
Recall number
Z-0849-2021
Initiated
December 15, 2020
Classification
Class I
Status
Terminated
Recalling firm
Penumbra Inc.
Quantity
27,499 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Name: Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing Catalog Number: 5MAXJET7KIT UDI Code: 00815948020962 Lot Number Range: C15441 thru C19176 F88882 thru F100278

Distribution pattern

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, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.

device · product 3 of 4

Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Z-0850-2021
Recall number
Z-0850-2021
Initiated
December 15, 2020
Classification
Class I
Status
Terminated
Recalling firm
Penumbra Inc.
Quantity
0 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Name: Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing Catalog Number: 5MAXJET7L138KIT UDI Code: 00815948021594 Lot Number Range: F97123 thru F98981 Note - none were distributed

Distribution pattern

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, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.

device · product 4 of 4

Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Z-0851-2021
Recall number
Z-0851-2021
Initiated
December 15, 2020
Classification
Class I
Status
Terminated
Recalling firm
Penumbra Inc.
Quantity
15 catheters

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Name: JET 7MAX (Penumbra JET 7 Xtra Flex + MAX Delivery Device) Catalog Number: J7XKIT132 UDI Code: 00815948021273 Lot Number Range: C21487 thru C21772 F97946 thru F98497

Distribution pattern

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, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.