LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837

FDA device recall Z-0495-2022 · posted 2022-01-13 · Terminated

Recall details

Recalling firm

Covidien Llc

Reason for recall

Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.

Action taken

URGENT MEDICAL DEVICE RECALL notification letters dated 12/2021 were sent to customers. Customer Action Required: 1. Please immediately quarantine and discontinue use of the affected item code with the associated lot number listed above. 2. Please return affected product as indicated below. All products from the affected item code and associated lot number must be returned. 3. If you have distributed the product item code and lot number listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory and email it to rs.anzrecalls@medtronic.com We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please do not hesitate to contact Azi Hosseini on +61 428 464 838, or azi.hosseini@medtronic.com

Root cause

Device Design

Status

Terminated

Product code

GEI

Quantity affected

504 devices

Distribution

Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.

Date initiated

2021-12-06

Date posted

2022-01-13

Date terminated

2023-05-11

Location

Mansfield, MA

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