Teleflex Recalls Percuvance Clip Applier Tool Tips Due to Connection Issues
Teleflex Medical is recalling 20,039 Percuvance Clip Applier Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a risk-of-harm product (surgical instrument malfunction) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Teleflex Medical is recalling 20,039 units of the Percuvance Clip Applier Tool Tip. This medical device is part of the Percutaneous Surgical System with 5mm attachments, indicated for penetrating soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize, and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
The recall was initiated because, for some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots, the jaws of the tool tips may close abruptly.
The affected products were distributed worldwide, including in the United States and various international locations. The specific lot numbers involved are 73A1600601, 73A1700239, 73C1600705, 73E1600177, 73E1600341, 73F1600411, 73F1600695, 73G1600727, 73H1600151, 73H1600342, and 73H1600660. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to…
- Manufacturer
- Teleflex Medical
- Affected units
- 20,039
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 (11)
- Lot #'s: 73A1600601
- 73A1700239
- 73C1600705
- 73E1600177
- 73E1600341
- 73F1600411
- 73F1600695
- 73G1600727
- 73H1600151
- 73H1600342
- and 73H1600660
Distribution
Part of a larger recall action
This product is one of 6 recalled by Teleflex Medical 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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