Aesculap DS Titanium Ligation Clips Recalled for Contraindication Update
Aesculap Implant Systems LLC is recalling DS Titanium Ligation Clips to update instructions for use, adding a contraindication for living donor nephrectomies.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity. The source text describes a labeling/instruction update to prevent misuse based on unvalidated third-party information, without reporting any specific injuries, illnesses, or deaths.
Plain-English summary
Aesculap Implant Systems LLC is recalling 9,621 units of DS Titanium Ligation Clips used in laparoscopic surgery. The recall covers clips distributed in the US and Canada, including various product numbers such as PL450SU and PL471SU, dating back five years.
The recall was initiated to add a contraindication to the Instructions for Use (IFU) stating that the clips should not be used for living donor nephrectomies. This action follows a 2017 publication that recommended the use of Aesculap DS Clips for kidney transplantation with living donors. The firm states that the information in this publication was not approved or validated by Aesculap Implant Systems LLC.
Healthcare providers and facilities that have received these clips should stop using them for living donor nephrectomies and review the updated instructions for use. No specific instructions for consumer disposal are provided in the source text, as these are surgical devices intended for professional medical use.
The recalled product
- Product
- DS Titanium Ligation Clip, used in laparoscopic surgery
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- Affected units
- 9,621
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Aesculap Implant Systems 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.
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