Z-1680-2022Class II

Optima Coil System Model OPTI0520CSF10. For endovascular embolization

Name: Z-1680-2022 Optima Coil System Model OPTI0520CSF10. For endovascular embolization
Creator: Balt USA, Llc
Published: 2022-07-26
License: https://open.fda.gov/license/

Balt USA, LLC / initiated 2022-07-26 / Open, Classified / root cause: supplier

FDA source

BALT USA, LLC began a recall of Optima Coil System Model OPTI0520CSF10. For endovascular embolization on 2022-07-26. FDA classified it as Class II and gives the reason as "Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1680-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-26
Posted: 2022-09-06
Recalling firm: Balt USA, LLC
Product: Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Product code: HCG Device, Neurovascular Embolization
Reason for recall: Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Root cause tag: supplier
FDA root cause: Under Investigation by firm
Action: On or about 07/15/2022, Balt USA LLC communicated an "URGENT FIELD SAFETY NOTICE (FSN)/PRODUCT RECALL" Letter informing customers that Balt became aware that finished goods were released and distributed to customers prior to the approval and release of a test report authorizing the use of existing material from an alternate supplier. On 08/08/2022 and updated/revised "URGENT MEDICAL DEVICE RECALL" letter was sent via certified mail to customers re-emphasizing the recall and providing updated instructions Customer are instructed to: -Inform within their hospital safety officers, pharmacists, head of neuroradiology and the neuroradiology department staff, as well as any other person. -Return to Balt USA any unused product from lot #F220600470: +Collect and put in quarantine the Optima products concerned by this recall and then return them to Balt USA through the usual "RMA" (Return Material Authorization) procedure by contacting Balt USA's Customer Service Department +Keepj informed Balt USA about the status of every unit of Optima products concerned by this recall; +Fulfill the "Notice of receipt" then return to Balt USA via the indicated contact. -If product from lot #F220600470 has been used, no further action is required. For question contact - Quality Department at [email protected] or telephone number 949-788-1443 or Fax Number: 949-788-1444
Quantity in commerce: 4 devices
Distribution: U.S.: AZ and FL O.U.S.: None
Product codes and lots: Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1680-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1680-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-06

Product code HCG

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)