Teleflex Percuvance Surgical System Recalled for Connection and Tip Defects
Teleflex Medical is recalling Percuvance 29cm Shaft surgical systems because the shaft connection may be compromised or tool tips 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 involves a medical device with a potential for injury during surgery (abrupt closure or compromised connection), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling the Percuvance 29cm Shaft, a percutaneous surgical system used for laparoscopic surgery. The recall affects 20,039 units distributed in the United States and internationally. The specific lots affected are listed in the source metadata.
The recall was initiated because the security of the connection between the shaft and the tool tip may be compromised for some products. Additionally, for certain other lots, the jaws of the tool tips may close abruptly. These defects could potentially affect the safety and efficacy of the surgical procedure.
Healthcare providers and facilities that have received these products should stop using them immediately. Teleflex Medical is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- Percuvance 29cm Shaft 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 soft tissue…
- Manufacturer
- Teleflex Medical
- Hazard
- 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 (20)
- Lot #'s: 73B1600168
- 73B1700525
- 73C1600057
- 73C1600152
- 73C1600267
- 73C1600327
- 73D1600176
- 73D1600481
- 73E1600001
- 73E1600662
- 73F1600520
- 73F1600594
- 73F1600697
- 73G1600015
- 73G1600177
- 73G1600178
- 73G1600557
- 73G1600730
- 73H1600567
- 73J1600182
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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Similar recalls
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