CLASS II Device recall · Reported 17 May 2017 · FDA Enforcement Report
Mederi Stretta Catheter and Accessory Kit recalled
Mederi Therapeutics is recalling Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the Mederi MDRF1, distributed nationwide in the US. The recall was initiated on 3 Apr 2017 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-2050-2017
- FDA event ID
- 76972
- Recalling firm
- Mederi Therapeutics, Norwalk, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Apr 2017
- FDA classified
- 8 May 2017
- Reported
- 17 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 3 Apr 2017 | Recall initiated by company | |
| 8 May 2017 | Classified by FDA | +35 days |
| 17 May 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product sterility compromised due to breach in sterile barrier package
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Where it was distributed
Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan and Egypt.
Questions about this recall
Is Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the Mederi MDRF1 recalled?
Yes. Mederi Therapeutics recalled Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the Mederi MDRF1 on 3 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2050-2017.
Why was it recalled?
Product sterility compromised due to breach in sterile barrier package
Which lots are affected?
Lot Numbers: 291ST-16 102ST-16 102ST-16R-1 102ST-16R-2 116ST-16R 116ST-16R2 116ST-16R3 116ST-16R4 139ST-16 139ST-16-1 139ST-16-2 139ST-16-3 144ST-16 209ST-16 227ST-16 243ST-16 276ST-15 286ST-16 290ST-16 291ST-16 299ST-16 306ST-16 310ST-15
Where was it sold?
Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan and Egypt.
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 21 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 Heart & Vascular Devices recalls
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| 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 |