HIGH
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect
HIGH
Abbott Recalls TactiFlex Ablation Catheter Over Tip Detachment Hazard
Abbott recalled 1,958 TactiFlex Sensor Enabled Ablation Catheters on September 10, 2025. The recall follows reports of tip detachment during removal from packaging. Patients and healthcare providers must stop using the device immediately.
Quick Facts at a Glance
- Recall Date
- September 10, 2025
- Hazard Level
- HIGH
- Brand
- Abbott
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
Hazard Information
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott or your healthcare provider for instructions. Notification method: Letter
Product Details
The recalled product is the TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F. The affected batch numbers include 8894357 and 8917490, among others. These products distributed worldwide were sold at multiple retailers.
The Hazard
Abbott identified a risk of tip detachment when removing the catheter from its packaging. This detachment poses a high hazard level, which can lead to complications during medical procedures.
Reported Incidents
There have been a limited number of reported incidents involving tip detachment. No specific numbers of injuries or deaths related to these incidents have been disclosed.
What to Do
Stop using the TactiFlex Ablation Catheter immediately. Follow the recall instructions provided by Abbott. For further information, contact Abbott or your healthcare provider.
Contact Information
For details, visit Abbott's website or call their customer service. More information is available at the FDA recall report link.
Key Facts
- Recall date: September 10, 2025
- Quantity recalled: 1,958 units
- Tip detachment hazard reported
- Class I recall due to high hazard level
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeAblation Catheter
Sold At
Multiple Retailers
Product Details
Brand
Categories
Model Numbers
GTIN 05415067034670
Batch Numbers: 8894357
8917490
8984945
10061309
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
SUCRALFATE
CGMP Deviations:
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Labeling: Incorrect or Missing Lot and/or Exp Date
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