Agency classClass IIOur severity:Severe FDA (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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Teleflex Medical
Category: Medical Device — Surgical Instrument
Hazard: structural-failure
surgical-intervention
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 →

Same manufacturer · Teleflex Medical

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Same hazard · structural failure