Medical Devices

Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems Labeling Issue

Use: The Trellis 6 and Trellis 8 Peripheral Infusion systems are used to treat blood clots that may form in the veins or arteries of the arms, hands, legs, or feet. The systems have two balloons that are inflated to isolate a clot. Medication is released between the balloons to reduce the size of or dissolve the clot so it can be removed. These devices are used by health care providers.

Recall Class: Class I

Date Recall Initiated:  December 10, 2014

Devices:

Manufacturing and distribution dates: 1126 units were distributed in the U.S. from June 6, 2014 to November 13, 2014.

Recalling Firm:
Covidien
4600 Nathan Ln N
Plymouth, Minnesota
55442-2890

Reason for Recall: A manufacturing error caused the balloon inflation ports to be mislabeled. This may cause the physician using the device to deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.

Depending upon the size of these clots, there is the possibility of serious patient injury or death.

Public Contact: Questions about this recall can be directed to Covidien customer service at 1-800-716-6700 between the hours of 7:00 a.m. and 7:00 p.m. CT or email CustomerServiceUS@Covidien.com.

FDA District: Minneapolis District Office

More Information about this Recall:

Customers were sent an urgent product recall letter dated December 15, 2014. The letter identified the affected product and actions for customers.

Customers were instructed to discontinue the use of the Trellis 6 and 8 infusion systems and return it to Covidien along with a response form included in the letter.

Customers with questions should contact their Covidien sales rep or to Covidien Service at 1-800-716-6700.

About Class I Recalls

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Products Being Recalled:

ProductModelLot Numbers
Trellis 6Model BVT6080109853174, 9864497, 9890772, 9890931, 9925676, 9932672, 9937308, 9937315, 9940474, 9940614, 9976340, 9978233, A001589, A001740
Trellis 6Model BVT6080309853331, 9887597, 9887695, 9887757, 9932042
Trellis 6Model BVT6120109854121, 9868214, 9868311, 9875472, 9875632, 9876174, 9883295, 9884788, 9884951, 9886196, 9886312, 9932096, 9968511, 9974109, 9974126, 9976472, 9977091, 9978862, A002299, A002423.
Trellis 6Model BVT6120309854124, 9892081, 9941213, 9971096, 9971139, 9976506, 9977140, 9978964, 9979548, A003021, A003121, A003651, A007900, A008492, A008603, A008687
Trellis 8CVT8080159895996, 9904675, 9910270, 9911926, 9912084, 9912200, 9922490, 9922584, 9922597, 9922601, 9922604, 9922606, 9922617, 9922620, 9922624, 9922635, 9923420, 9924840, 9928078, 9932274, 9933341, 9933774, 9933839, 9933934, 9934029, 9934440, 9934633, 9934686, 9936420, 9937544, 9937660, 9942679, 9943032, 9945436, 9948145, 9949409, 950000, 9950703
Trellis 8CVT8080259904237, 9906429, 9910270, 9912003, 9912117, 9912261, 9922644, 9922658, 9922661, 9922663, 9922739, 9922862, 9922868, 9923391, 9923401, 9923405, 9923428, 9923437, 9923454, 9924796, 9924802, 9924826, 9924847, 9924853, 9928334, 9928629, 9929004, 9929248, 9929344, 9933577, 9933797, 9933903, 9934553, 9934772, 9935134, 9935174, 9935241, 9935245, 9935471, 9935523, 9935757, 9935889, 9936140, 9936631, 9936680, 9936702, 9936735, 9937706, 9938500, 9938960, 9939918, 9939985, 9940234, 9940687, 9940916, 9948001, 9948544, 9949603, 9950150, 9950722, 9951391, 9952404, 9952785, 9952844, 9959913
Trellis 8CVT8120159904401, 9904676, 9910934, 9912387, 9922742, 9922793, 9922886, 9922892, 9922902, 9922904, 9922917, 9923224, 9923226, 9923237, 9923268, 9923275, 9923398, 9923446, 9923453, 9924832, 9932594, 9933474, 9933813, 9933924, 9934192, 9934730, 9936820, 9937095, 9937806, 9942701, 9943235, 9945140
Trellis 8CVT8120259910342, 9911492, 9911683, 9911812, 9912503, 9922498, 9922750, 9922753, 9922873, 9922911, 9923246, 9923403, 9923404, 9923409,, 9923426, 9923442, 9923450, 9923457, 9924848, 9925351, 9933666, 9934311, 9934575, 9934700, 9935143, 9935199, 9935494, 9935636, 9935900, 9936109, 9936173, 9936570, 9936597, 9936848, 9937896, 9937968, 9938060, 9938219, 9938831, 9938896, 9941711, 9945304, 9947559, 9948088, 9949321, 9949934, 9950324, 9951247, 9951521, 9952927, 9957277, 9957530, 9959854, 9959944, 9960241, 9960324, 9960635, 9960807, 9961583, 9961682, 9962504, 9963558, 9964120, 9964347, 9964448, 9965066, 9965335, 9966329, 9966429, 9966999, 9967656, 9967694, 9968180, 9969396, 9972428, 9972429, 9972819, 9972867, 9972966
Trellis 8EVT8080159912933, 9913003, 9913878, 9928819, 9929499, 9929826, 9929913, 9929937, 9929971, 9929980, 9930297, 9930464, 9930797, 9930951, 9931141, 9931509, 9931544, 9955126, 9955275, 9956434, 9970652, 9929826, 9930951, 9955126, 9955275, 9956347
Trellis 8EVT8080259912629, 9913219, 9913619, 9913647, 9913792, 9928202, 9928286, 9928957, 9929625, 9929921, 9929942, 9929975, 9929984, 9930119, 9954578, 9954720, 9955164, 9955302, 9956600, 9957360, 9966889, 9968025, 9970097, 9954578, 9955164
Trellis 8EVT812015V019928226, 9928916, 9931680, 9954559, 9954683, 9955186, 9956478, 9956505, 9956660, 9961108, 9966680, 9966940, 9967242, 9968054, 9968734, 9969632, 9954559, 9966680
Trellis 8EVT812025V019929653, 9953991, 9954138, 9928255, 9929653, 9929681, 9930088, 9954138, 9954398, 9954500, 9954604, 9955002, 9955236, 9957446, 9959050, 9959087, 9960088, 9960218, 9961172, 9965700, 9965782, 9967620, 9967622, 9975240, 9975547, 9977238, A000273

 

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