Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 30, 2019
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-o-lok ligating clips to soft tissue during laparoscopic surgery.
There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the fun…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Teleflex Medical recalled Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5m… - a moderate-severity action.
Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5m… was recalled by Teleflex Medical in January 30, 2019. Reason: There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly brea…. Check the official notice for the remedy. Verify recall #Z-0753-2019 with the FDA Devices before acting.
The recall
Teleflex Medical issued this moderate-severity FDA Devices recall-There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly brea….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- January 30, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0753-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0753-2019) was formally reported on January 30, 2019, with the manufacturer initiating the action on January 3, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Teleflex Medical is listed as the recalling firm, operating out of Morrisville, NC. Federal records list the affected scope as 1751 units.
The documented reason for this recall is: There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip.… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Iran, Ireland, Italy, Japan, Lebanon, Netherlands, Qatar, Romania, Saudi Arabia, Sing…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1751 units
Related Recalls
6
0 from same agency
Product description
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-o-lok ligating clips to soft tissue during laparoscopic surgery.
Reason for recall
There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0753-2019 |
| Date reported | January 30, 2019 |
| Date initiated | January 3, 2018 |
| Recalling firm | Teleflex Medical |
| Firm location | Morrisville, NC |
| Affected scope | 1751 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Iran, Ireland, Italy, Japan, Lebanon, Netherlands, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0753-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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-o-lok ligating clips to soft tissue during laparoscopic surgery.. Recalled by Teleflex Medical. Units affected: 1751 units.
Why was this product recalled? ▼
There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 30, 2019. Severity: Moderate. Recall number: Z-0753-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and countries of: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0753-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 30, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.