Z-1527-2014Class III

PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter...

Name: Z-1527-2014 PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter...
Creator: Laurimed LLC
Published: 2014-04-07
License: https://open.fda.gov/license/

Laurimed, LLC / initiated 2014-04-07 / Terminated / root cause: design

FDA source

Laurimed LLC began a recall of PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal... on 2014-04-07. FDA classified it as Class III and gives the reason as "The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1527-2014
Classification: Class III
Status: Terminated
Initiated: 2014-04-07
Posted: 2014-04-30
Terminated: 2014-05-14
Recalling firm: Laurimed, LLC
Product: PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
Product code: ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Reason for recall: The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Root cause tag: design
FDA root cause: Component design/selection
Action: All direct accounts were notified on April 8, 2014 with an Urgent: Medical Device Recall of PolypVac Microdebrider letter, sent by first class mail. The letter identified the affected product, the reason for the recall, and stated that the firm is in the process of implementing corrections. The firm is requesting that all unused lots be returned to them. Replacement devices will sent to customers. In addition, customers are to complete the attached Lot Information sheet. Questions should be directed to [email protected] or 650-587-5296.
Quantity in commerce: 58
Distribution: Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
Product codes and lots: Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1527-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1527-2014	Class III	Terminated	Voluntary: Firm initiated	2014-05-07	2014-04-30

Product code ERL

K133133Class IILaurimed Polypvac MicrodebriderLaurimed, LLC / cleared 2013-12-23

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)