DS Titanium Ligation Clip, used in laparoscopic surgery

FDA Device Recall #Z-1290-2018 — Class II — January 22, 2018

Recall Summary

Recall Number Z-1290-2018
Classification Class II — Moderate risk
Date Initiated January 22, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Aesculap Implant Systems LLC
Location Center Valley, PA
Product Type Devices
Quantity 9621

Product Description

DS Titanium Ligation Clip, used in laparoscopic surgery

Reason for Recall

Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for kidney transplantation with living donors. The information from this publication was not approved or validated by the firm.

Distribution Pattern

US and Canada distribution

Lot / Code Information

DS Clips - Product Numbers PL450SU DS SINGLE FIRE LIG.CLIPS PL471SU DS SINGLE FIRE LIG.CLIP L W/LATCH PL453SU DS SINGLE FIRE LIG.CLIP SM PL475SU DS SINGLE FIRE LIG.CLIP XL W/LATCH PL459SU DS SINGLE FIRE LIG.CLIP M PL462SU DS SINGLE FIRE LIG.CLIP ML PL465SU DS SINGLE FIRE LIG.CLIP ML W/LATCH PL468SU DS SINGLE FIRE LIG.CLIP L (all clips going back 5 years)

Other Recalls from Aesculap Implant Systems LLC

Recall # Classification Product Date
Z-2518-2023 Class II For intraventricular indications mainly used fo... Jul 20, 2023
Z-2146-2023 Class II Aesculap Surgical Needle, straight, 3 1/2", (90... May 18, 2023
Z-1569-2023 Class II Aesculap Caiman Articulating D5/360MM - An elec... Mar 21, 2023
Z-1430-2023 Class II Caspar Cervical Retractor (CCR) Basket ME754 - ... Feb 23, 2023
Z-1638-2022 Class II Aesculap ENNOVATE SET SCREW STERILE-implants ar... Jul 15, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.