CLASS II ONGOING Device recall · Reported 24 Aug 2022 · FDA Enforcement Report
Echelon -14 Micro Catheter recalled by Micro Therapeutics
Micro Therapeutics is recalling Echelon -14 Micro Catheter, distributed nationwide in the US. The recall was initiated on 30 Jun 2022 and the FDA has classified it as Class II.
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-1557-2022
- FDA event ID
- 90622
- Recalling firm
- Micro Therapeutics, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jun 2022
- FDA classified
- 18 Aug 2022
- Reported
- 24 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 30 Jun 2022 | Recall initiated by company | |
| 18 Aug 2022 | Classified by FDA | +49 days |
| 24 Aug 2022 | 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
Outer carton packaging of microcatheters were exposed to wet substance during transport.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only
Where it was distributed
US Nationwide Distribution: None OUS: Brazil
Questions about this recall
Why was it recalled?
Outer carton packaging of microcatheters were exposed to wet substance during transport.
Which lots are affected?
Lot # B262322 UDI: (00) 847536005983
Where was it sold?
US Nationwide Distribution: None OUS: Brazil
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
1 other product · FDA event 90622This product is part of a recall event; the main page for the event is Echelon -14, 45 Tip Shape recalled by Micro Therapeutics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Echelon -14, 45 Tip Shape recalled by Micro Therapeutics | Micro Therapeutics | Packaging Defects | Nationwide |
More recalls from Micro Therapeutics
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS I | Medtronic Pipeline Vantage Embolization Device recalled | Micro Therapeutics | Other | Nationwide |
| Device | CLASS I | Medtronic Pipeline Vantage Embolization Device recalled | Micro Therapeutics | Other | Nationwide |
| Device | CLASS II | The Apollo Onyx Delivery Microcatheter recalled by Micro Therapeutics | Micro Therapeutics | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |