FDA Device recall Z-1661-2013

VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombo…

FDA Device
Class II
terminated
Published 2013-07-10

On 2013-07-10 the FDA classified a Class II recall of VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombo… by Djo, citing DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1661-2013
Classification	Class II
Status	terminated
Initiated	2013-05-28
Published	2013-07-10
Last updated	2026-09-13 11:53 UTC
Company	Djo
Distribution	US

Product

VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.

Reason

DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).

Identifiers

code_info	Model Numbers: 30B-B and 30BI-B. Serial Numbers: E00026 E00029 E00030 E00031 E00036 E00039 E00045 E00… Model Numbers: 30B-B and 30BI-B. Serial Numbers: E00026 E00029 E00030 E00031 E00036 E00039 E00045 E00050 E00051 E00052 E00053 E00056 E00057 E00058 E00060 E00143 E00147 E00151 E00156 E00163 E00169 E00175 E00178 E00184 E00191 E00200 E00201 E00203 E00205 E00206 E00211 E00211 E00222 E00227 E00234 E00236 E00238 E00239 E00240 E00241 E00242 E00243 E00245 E00246 E00247 E00248 E00250 E00252 E00258 E00260 E00261 E00262 E00264 E00267 E00269 E00271 E00272 E00273 E00274 E00276 E00281 E00283 E00289 E00296 E00298 E00301 E00303 E00305 E00306 E00308 E00313 E00314 E00315 E00317 E00321 E00322 E00326 E00329 E00330 E00332 E00335 E00336 E00337 E00339 E00340 E00342 E00344 E00347 E00348 E00351 E00352 E00357 E00358 E00363 E00368 E00370 E00371 E00373 E00375 E00376 E

code_info

Model Numbers: 30B-B and 30BI-B. Serial Numbers: E00026 E00029 E00030 E00031 E00036 E00039 E00045 E00…

Model Numbers: 30B-B and 30BI-B. Serial Numbers: E00026 E00029 E00030 E00031 E00036 E00039 E00045 E00050 E00051 E00052 E00053 E00056 E00057 E00058 E00060 E00143 E00147 E00151 E00156 E00163 E00169 E00175 E00178 E00184 E00191 E00200 E00201 E00203 E00205 E00206 E00211 E00211 E00222 E00227 E00234 E00236 E00238 E00239 E00240 E00241 E00242 E00243 E00245 E00246 E00247 E00248 E00250 E00252 E00258 E00260 E00261 E00262 E00264 E00267 E00269 E00271 E00272 E00273 E00274 E00276 E00281 E00283 E00289 E00296 E00298 E00301 E00303 E00305 E00306 E00308 E00313 E00314 E00315 E00317 E00321 E00322 E00326 E00329 E00330 E00332 E00335 E00336 E00337 E00339 E00340 E00342 E00344 E00347 E00348 E00351 E00352 E00357 E00358 E00363 E00368 E00370 E00371 E00373 E00375 E00376 E

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1661-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.