Z-2050-2017Class II

Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the...

Name: Z-2050-2017 Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the...
Creator: Mederi Therapeutics, Inc
Published: 2017-04-03
License: https://open.fda.gov/license/

Curon Medical, Inc. / initiated 2017-04-03 / Terminated / root cause: packaging

FDA source

Mederi Therapeutics, Inc began a recall of Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease... on 2017-04-03. FDA classified it as Class II and gives the reason as "Product sterility compromised due to breach in sterile barrier package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2050-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-03
Posted: 2017-05-08
Terminated: 2017-10-10
Recalling firm: Curon Medical, Inc.
Product: 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
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Product sterility compromised due to breach in sterile barrier package
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Mederi issued initial recall on March 29, 2017, and on April 3, 2017, with a corrected recall letter requesting users identify product and set aside for an inspection by Mederi personnel. Once the inspection is completed return the Acknowledgement Form Customer Service, return via eFax at 888-215-9883, or email to [email protected]. Mederi will provide FedEx labels and ensure appropriate packaging for the return. For further questions, please call (203) 930-9900.
Quantity in commerce: 1458 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2050-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2050-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-08

Product code GEI

K152317Class IIStretta CatheterMederi Therapeutics, Inc. / cleared 2015-09-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)