Z-0527-2018Class II

Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is...

Name: Z-0527-2018 Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is...
Creator: Angiodynamics, Inc.
Published: 2017-06-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-06-05 / Terminated

FDA source

Angiodynamics, Inc. began a recall of Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, REF 806-10... on 2017-06-05. FDA classified it as Class II and gives the reason as "The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0527-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-05
Posted: 2018-02-05
Terminated: 2018-09-11
Recalling firm: Boston Scientific Corporation
Product: Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
Product code: NEY System, Ablation, Microwave And Accessories
Reason for recall: The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
FDA root cause: Under Investigation by firm
Action: URGENT VOLUNTARY MEDICAL DEVICE RECALL Letters and Response Forms (dated June 5, 2107) were sent to consignees via FedEx on June 5, 2017. The letter identified the affected product, problem and actions to be taken.
Quantity in commerce: 14,353 units in total
Distribution: Worldwide distribution - US Nationwide
Product codes and lots: Lots: 15310414, 15320417, 15340425, 15360433, 15370437, 15380441, 15390445, 15400451, 15470470, 15480472, 16050496, 16070501, 16130515, 16160525, 16190536, 16250558, 16320574, 16330579, 16420606, 16440612, 16460620, 16480630, 16500637, 17010646, 17030654, 17040659, 17070667, 17090672.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0527-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0526-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-05
Z-0527-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-05
Z-0528-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-05
Z-0529-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-05
Z-0530-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-05
Z-0531-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-05

Product code NEY

K094021Class IIAcculis Accu2i Pmta Applicator Model Accu2iMicrosulis Medical Limited / cleared 2010-08-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)