Teleflex Percuvance Percutaneous Shaft Recall Due to Tip Breakage Risk
Teleflex Medical is recalling 1,962 units of Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially requiring surgical intervention.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that 'surgical intervention may be required' if the defect occurs, which constitutes a significant injury risk and aligns with the rubric criteria for a Severe (4) rating.
Plain-English summary
Teleflex Medical is recalling 1,962 units of the Percuvance Percutaneous Shaft 36cm (PCVSHL3). The product is a percutaneous surgical system used to penetrate soft tissue to access certain areas of the abdomen during laparoscopic surgery. The system is used to grasp, manipulate, cut, cauterize, and deliver Hem-o-lok ligating clips.
The recall is issued because there is a potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece breaks off, it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.
The affected units were distributed worldwide, including the United States (nationwide) and Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Iran, Ireland, Italy, Japan, Lebanon, Netherlands, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, and the United Arab Emirates. Specific lot numbers are listed in the official recall documentation.
The recalled product
- Product
- Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver He
- Manufacturer
- Teleflex Medical
- Affected units
- 1,962
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)
- Batch/Lot Numbers: 73A1700535
- 73B1600170
- 73B1700073
- 73B1700523
- 73B1700646
- 73C1600058
- 73C1600706
- 73D1600482
- 73F1600086
- 73G1600207
- 73G1600468
- 73G1600573
- 73G1700041
- 73G1700311
- 73G1700577
- 73H1600509
- 73H1700513
- 73H1700526
- 73H1700531
- 73H1700532
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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