CLASS I Device recall · Reported 16 Mar 2016 · FDA Enforcement Report
Ultra 8 IAB: 40cc recalled by Arrow International, Inc.
Arrow International, Inc., Division of Teleflex Medical is recalling Ultra 8 IAB: 40cc, distributed nationwide in the US. The recall was initiated on 10 Feb 2016 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1058-2016
- FDA event ID
- 73266
- Recalling firm
- Arrow International, Inc., Division of Teleflex Medical, Everett, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 10 Feb 2016
- FDA classified
- 10 Mar 2016
- Reported
- 16 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 10 Feb 2016 | Recall initiated by company | |
| 10 Mar 2016 | Classified by FDA | +29 days |
| 16 Mar 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Product as listed by the FDA
Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
Where it was distributed
Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
Questions about this recall
Why was it recalled?
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Which lots are affected?
Batch: 18F14B0044 18F14B0045 18F14E0060 18F14F0019 18F14G0067 18F14H0002 18F14J0026 18F15A0033 18F15B0009 18F15B0019 18F15C0012 18F15D0016 18F15D0037 18F15D0044 18F15F0001
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 73266This product is part of a recall event; the main page for the event is Percutaneous Insertion Tray recalled by Arrow International, Inc..
More recalls from Arrow International, Inc., Division of Teleflex Medical
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | FiberOptix Ultra 8 IAB: 40cc recalled by Arrow International, Inc. | Arrow International, Inc., Division of Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Percutaneous Insertion Tray recalled by Arrow International, Inc. | Arrow International, Inc., Division of Teleflex Medical | Other | Nationwide |
| Device | CLASS I | UltraFlex IAB recalled by Arrow International, Inc. | Arrow International, Inc., Division of Teleflex Medical | Other | Nationwide |
| Device | CLASS I | FiberOptix Ultra 8 IAB: 30cc The Arrow¿ IAB is utilized recalled | Arrow International, Inc., Division of Teleflex Medical | Other | Nationwide |
| Device | CLASS I | UltraFlex IAB recalled by Arrow International, Inc. | Arrow International, Inc., Division of Teleflex Medical | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |