Agency classClass IIOur severity:Severe FDA (Devices)·Z-0747-2021·Announced 2021-01-06

FDA Recalls Covidien TA Auto Suture Vascular Staplers Due to Damaged Components

The FDA is recalling specific lots of Covidien TA Auto Suture Vascular Staplers because a damaged internal component may prevent adequate hemostasis or cause tissue damage.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a surgical device that can lead to significant injury, including sepsis and tissue damage.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling specific lots of the Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. The device is intended for abdominal, gynecological, pediatric, and thoracic surgical procedures for resection or transection of tissue. The recall involves 3,255 units distributed in the United States and 3,574 units distributed outside the U.S.

The recall is being issued because the devices may contain a damaged internal component. This defect could impede staple deployment, resulting in incomplete staple formation and a non-functional staple line. Such a failure may prevent adequate hemostasis or lead to anastomotic leak, pneumothorax, tissue damage, or other delayed secondary complications including infection, peritonitis, and sepsis.

The affected lot numbers are P0B1142MY, P0C1515MY, P0E0634MY, P0E1353MY, P0C0492MY, P0D1454MY, P0E1352MY, P0G0601Y, and P0C0493MY. The associated UDI codes are 10884521043145 and 20884521043142. Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected devices.

The recalled product

Product: Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
Manufacturer: Covidien Llc
Category: Medical Device — Surgical Staplers
Hazard: incomplete-staple-formation
tissue-damage
infection

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

Lot Numbers: P0B1142MY
P0C1515MY
P0E0634MY
P0E1353MY
P0C0492MY
P0D1454MYP0E1352MY
P0G0601Y
P0C0493MY UDI: 10884521043145
20884521043142

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Covidien Llc

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Same hazard · incomplete staple formation