Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported April 29, 2015
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or…
Laax, Inc. recalled TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an… - a critical-severity action.
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an… was recalled by Laax, Inc. in April 29, 2015. Reason: Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing o…. Check the official notice for the remedy. Verify recall #Z-1461-2015 with the FDA Devices before acting.
The recall
Laax, Inc. issued this critical-severity FDA Devices recall-Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing o….
- Critical
- severity level
- Class I
- classification
- April 29, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1461-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1461-2015) was formally reported on April 29, 2015, with the manufacturer initiating the action on March 25, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Laax, Inc. is listed as the recalling firm, operating out of Livermore, CA. Federal records list the affected scope as ~ 4,154 total units in US - both model numbers.
The documented reason for this recall is: Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and countries of:Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy Netherland, Norway, Poland, Qatar, Slovenia, Spa…. 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, 3 from FDA Devices - 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 - 40,322 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
~ 4,154 total units in US - both model numbers
Related Recalls
6
3 from same agency
Product description
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Reason for recall
Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1461-2015 |
| Date reported | April 29, 2015 |
| Date initiated | March 25, 2015 |
| Recalling firm | Laax, Inc. |
| Firm location | Livermore, CA |
| Affected scope | ~ 4,154 total units in US - both model numbers |
| Distribution | Worldwide Distribution: US (nationwide) and countries of:Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy Netherland, Norway, Poland, Qatar, Slovenia, Spain, Saudi Arabia, Sw… |
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-1461-2015) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).. Recalled by Laax, Inc.. Units affected: ~ 4,154 total units in US - both model numbers.
Why was this product recalled? ▼
Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2015. Severity: Critical. Recall number: Z-1461-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and countries of:Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy Netherland, Norway, Poland, Qatar, Slovenia, Spain, Saudi Arabia, Sweden, Switzerland, Turkey and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1461-2015) 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 April 29, 2015. 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.