The Recall Desk
SevereFDA (Devices)·Z-0753-2019·Announced 2019-01-30

Teleflex Percuvance Percutaneous Shaft Recall for Potential Tip Breakage

Teleflex Medical is recalling Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially compromising the tool's security.

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 recall is classified as FDA Class II and involves a structural defect in a surgical instrument that could compromise tool security and require surgical intervention, meeting the criteria for a Severe rating.

Plain-English summary

Teleflex Medical is recalling 1,751 units of the Percuvance Percutaneous Shaft 29cm (PCVSH3). The product is part of a Percutaneous Surgical System used to penetrate soft tissue to access certain areas of the abdomen during laparoscopic surgery.

The recall is due to a potential defect where a piece of the distal tip on the shaft may 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 and countries such as Australia, Belgium, China, and Germany. Specific batch and lot numbers are listed in the official recall documentation. Users should stop using the affected devices and contact Teleflex Medical for further instructions.

The recalled product

Product
Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 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 Hem
Manufacturer
Teleflex Medical
Category
Medical Device — Surgical Instrument
Hazard
Affected units
1,751

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)

  • Batch/Lot Numbers: 73A1700531
  • 73B1700180
  • 73F1700583
  • 73F1700584
  • 73F1700585
  • 73H1700728
  • 73J1600394
  • 73J1700072
  • 73J1700073
  • 73J1700074
  • 73J1700554

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Teleflex Medical

See all →

Same hazard · structural failure

See all →